MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 14 VOLT LITHIUM ION BATTERY SET; VENTRICULAR (ASSISST) BYPASS

Model Number 2465

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the 14v li-ion battery not being accepted for charge was able to be confirmed.The 14v li-ion battery (serial number: (b)(4) was returned for analysis and tested.The battery was connected to a mock loop and was able to operate a pump; however, when placed in the universal battery charger (ubc), the battery was not accepted for charge due to an issue with the smbus.The battery was cut open to perform circuit analysis.The voltages along the smbus lines were measured and pin 2 on the diode d21 was found to be shorted to ground.Pin 2 is associated with smb_c.No further testing was conducted.The root cause of the reported event was unable to be conclusively determined through this investigation.The device history records for the 14v li-ion battery were unable to be reviewed due to the records being maintained by the vendor and are unavailable.Heartmate 3 patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿, explain all battery charger alarms, and the actions to take when a battery charger alarm occurs.Heartmate 3 patient handbook section 6 "caring for the equipment" and heartmate 3 ifu section 8 "equipment storage and care" describe how to care for, maintain, and store the 14v batteries.Heartmate 3 patient handbook section 10 and heartmate 3 ifu section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 left ventricular assist device (lvad).Heartmate 3 patient handbook and heartmate 3 ifu section 3 ¿powering the system¿ explain the various ways to power the heartmate iii lvas, including how to use the 14v batteries.This section informs the user of how to charge the 14v batteries using the universal battery charger.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that one of the patient's batteries was no longer holding a charge.The battery was submitted for warranty replacement.

• Brand Name: HEARTMATE 14 VOLT LITHIUM ION BATTERY SET
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14017332
• MDR Text Key: 289614555
• Report Number: 2916596-2022-10194
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: 00813024010692
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2024
• Device Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: SV035-B062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White